Natco Pharma and Cipla, two leading manufacturers of imatinib mesylate in India will not be withdrawing their brands from the market even if government notifies the grant of EMR to Novartis in the gazette. Both the companies have stated that as the grant of EMR to Glivec is questionable, there is no need to take the brands out of market.

In the wake of the stand took by Natco and Cipla, Novartis would opt for a legal course to assert its right as the holder of EMR for Glivec. While responding to Pharmabiz query on Novartis’ stand on enforcing the EMR in India, Ranjit Shahani, CEO, Novartis India, said that the company would pursue the exclusive right rigorously. “Since this is the first instance of an EMR in India, we have to pioneer the defending route as well in the country,” he said.

When asked about the high cost of the therapy using Glivec, which makes the drug unaffordable to Indian patients, Shahani said “as per our market information, good majority of the patients who are using Glivec in India are not paying from their pocket as they get the cost reimbursed. And, our policy is that the patients, who cannot afford the price but treatment is inevitable, we ensure them get the drug free of cost,” he added.

Currently in India there is no model available as far as enforcing exclusive marketing right while a host of manufacturers are already in the market. In addition, there is no well-defined government mechanism as well to force other players to stop marketing when the EMR is granted to one company.

However, Amar Lulla, joint managing director, Cipla said that the company will defend itself if there is a move against it for marketing this product. “However, since there is no official information so far forcing us to take the product off the market, we have not thought about responding to the EMR,” he said

The sources from Natco, which markets the product in the brand name Veenat, also clearly stated that there is no question of withdrawing the product in the wake of an unjustifiable EMR. The Natco official said that the EMR granted by the Patent Controller of India will be challenged by us as the authority has overlooked the original invention data of the drug, which disqualifies the EMR. application of Novartis for consideration.

However, since the Gazette notification on the EMR grant is yet to come out, the companies are still waiting for the official information on the EMR to kick-start the legal battle. The other local manufacturers of the drug in India are Ranbaxy, Sun, Intas and the Mumbai based Camlin Pharma.